NCT00785239

Brief Summary

The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with the CryoSpray Ablation™ System post-510K approval.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

Same day

First QC Date

November 4, 2008

Last Update Submit

June 23, 2015

Conditions

Lung CancerEmphysemaChronic BronchitisCOPDAsthmaSarcoidosisMesothelioma

Keywords

Malignant Airway DiseaseBenign Airway DiseaseLung CancerEmphysemaChronic BronchitisCOPDAsthmaSarcoidosisMesotheliomaCryoSpray AblationCryotherapyCryosprayCryo

Outcome Measures

Primary Outcomes (1)

  • Primary objectives of the study are to enable analysis of patient outcomes 2 years following final treatment and estimate the effectiveness of the device in eradicating, decreasing and downgrading of the diseases.

    2 years post-treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of subjects treated with the CryoSpray Ablation™ System in the airway or for thoracic diseases.

You may qualify if:

  • Patients who are being treated with the CryoSpray Ablation™ System for lung and for thoracic diseases.

You may not qualify if:

  • Subjects with thoracic or airway obstructions and diseases who were not treated with the CryoSpray Ablation™ System.
  • Subjects under the age of 18 years.
  • Subjects unable to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008.

    PMID: 16301023BACKGROUND

  • Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4.

    PMID: 10385730BACKGROUND

  • Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7. doi: 10.1016/s0016-5085(00)70136-3.

    PMID: 10734018BACKGROUND

  • Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54. doi: 10.1016/0016-5085(94)90123-6.

    PMID: 8076761BACKGROUND

  • Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.

    PMID: 8995932BACKGROUND

  • Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8.

    PMID: 14629105BACKGROUND

  • Cash BD, Johnston LR, Johnston MH. Cryospray ablation (CSA) in the palliative treatment of squamous cell carcinoma of the esophagus. World J Surg Oncol. 2007 Mar 16;5:34. doi: 10.1186/1477-7819-5-34.

    PMID: 17367523BACKGROUND

  • Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.

    PMID: 10349923BACKGROUND

  • Field JK, Youngson JH. The Liverpool Lung Project: a molecular epidemiological study of early lung cancer detection. Eur Respir J. 2002 Aug;20(2):464-79. doi: 10.1183/09031936.02.00290202.

    PMID: 12212983BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsEmphysemaBronchitis, ChronicPulmonary Disease, Chronic ObstructiveAsthmaSarcoidosisMesothelioma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Mesothelial

Study Officials

  • William Krimsky, M.D.

    Franklin Square Hospital Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

April 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

June 25, 2015

Record last verified: 2015-06